The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Atellica Ch Magnesium (mg).
| Device ID | K162399 |
| 510k Number | K162399 |
| Device Name: | Atellica CH Magnesium (Mg) |
| Classification | Photometric Method, Magnesium |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE, PO BOX 6101 MS 514 Newark, DE 19711 |
| Contact | Laura J. Duggan |
| Correspondent | Laura J. Duggan SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE, PO BOX 6101 MS 514 Newark, DE 19711 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595597 | K162399 | 000 |